Comparing the Prognosis of Patients With HCC and PVTT Treated With Surgery Versus Locoregional Therapy.

Chen Xiaoping

Status: Active, not recruiting

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Liver resection; Procedure: Locoregional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06248528

CHALLENGE-01

Details and patient eligibility

About

Hepatocellular carcinoma is prone to invade the portal vein and form portal vein thrombosis, and patients in this period are directly included in the advanced stages, i.e. Barcelona clinical liver cancer stage C. For the treatment of PVTT, there are differences between Eastern and Western guidelines, with systemic drugs being the standard of care in Western countries, while surgical treatment is often actively practiced in the Asia-Pacific region. More research is needed to explore the differences between these two approaches.

Full description

Hepatocellular carcinoma is prone to invade the portal vein and form portal vein thrombosis, and patients in this period are directly included in the advanced stages, i.e. Barcelona clinical liver cancer stage C. For the treatment of PVTT, there are differences between Eastern and Western guidelines, with systemic drugs being the standard of care in Western countries, while surgical treatment is often actively practiced in the Asia-Pacific region. In recent years, breakthroughs have been made in the treatment of advanced HCC, and systemic drug combinations such as PD-1 inhibitors combined with targeted therapies, and local area therapy combined with systemic therapy have shown excellent anti-tumor effects. Postoperative adjuvant therapy is also advancing, and the combination of adjuvant systemic medications for patients after PVTT has also been effective in reducing postoperative recurrence. Which approach is better for PVTT patients needs to be explored in depth.

We launched the CHALLENGE-01 study in October 2023. The study consists of two phases: the first phase involves retrospective data collection from 2019 to 2023 and prospective follow-up of survival information. Specifically, the liver resection+ PD-1 inhibitor + lenvatinib (LRPL) cohort included 225 cases, the TACE + PD-1 inhibitor + lenvatinib (TPL) cohort included 205 cases, and the surgery-only treatment cohort included 200 cases as an additional control group. Data analysis from the first phase of the study showed that the median follow-up times for the LRPL and TPL cohorts were 31.6 months and 22.5 months, respectively. Based on retrospective cohort data, we calculated the sample size required for the prospective study (446) and formally initiated the second-phase prospective clinical trial in January 2024. The study completed the required enrollment from nine centers in China by December 31, 2024, but has not yet reached the primary endpoint (OS).

Enrollment: 1,076 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18-75 years
• Pathological type is HCC, and with PVTT
• No extrahepatic HCC
• Eastern Cooperative Oncology Group (ECOG) performing status of 0-1 and Child-Pugh grade A for the liver resection group
• ECOG performing status of 0-2 and Child-Pugh grade A-B for the locoregional-based group
• Adequate hematologic and organ function

Exclusion criteria

• Any history of other malignant tumors or recurrent HCC
• Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
• Any persistent serious liver resection or locoregional therapy-related complications
• Esophageal and/or gastric variceal bleeding within 6 months
• Inability or refusal to comply with the treatment and monitoring
• Participation in other clinical trials

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,076 participants in 2 patient groups

Liver resection-based group

Experimental group

Description:

Patients in the liver resection-based group received adjuvant PD-1 inhibitors plus targeted drugs following liver resection.

Treatment:

Procedure: Liver resection

Locoregional treatment-based group

Active Comparator group

Description:

Patients in the locoregional treatment-based group received PD-1 inhibitors plus targeted drugs following locoregional therapy.

Treatment:

Procedure: Locoregional therapy